Bausch and Lomb currently has approximately 200 medical devices dedicated to eye surgery. The Medical Affairs Manager provides support to the Clinical Evaluation Group for ongoing assessment of the safety and performance clinical data of the Bausch+Lomb Surgical Medical Devices Portfolio. He or she supports Post-Market Clinical Follow-up activities to answer MDR requirements. The Medical Manager reports directly to the Director, Surgical Global Medical Devices/Clinical Evaluation Group.
MAJOR AREAS OF RESPONSIBILITY Creation and update of Clinical Evaluation Reports to ensure MDR compliance.
Creation of the summary of safety and clinical performance (when required).
Works closely and effectively with cross-functional teams to ensure consistency between highly linked documents: risk analysis, clinical evaluation report, PMCF plan & activities, PMS reports, and IFU.
Identifies potential residual risks, new risks, and/or safety issues to plan, implement, and coordinate appropriate level and design of PMCF activities for our surgical portfolio.
Interacts with third-party vendors in the creation or update of the CERs and the development of the PMCF activities (e.g., plans and reports) to support a timely and successful submission and approval by global regulatory authorities.
Reports to global staff any risk for failure of keeping Medical Devices on the market.
CONTACTS (INTERNAL AND EXTERNAL) Internal: Global Clinical Evaluation Group, Clinical and Medical Affairs teams, Regulatory Affairs, Clinical services, Legal Manufacturer Quality teams, Post Market Surveillance teams, International Marketing Departments.
External: Third-party vendors, Notified Bodies.
EDUCATION/COMPETENCY REQUIREMENTS Education: MD, MS, or higher degree in scientific/biological/clinical discipline.
Experience: Minimum 5 years in Medical Affairs and/or Vigilance in the field of Surgical Medical devices. Clinical research expertise. Ideally knowledge of medical devices used in Refractive, Cataract, and Vitreoretinal surgery.
Competencies: Strong operational/strategic thinking and networking skills, analytical expertise in understanding complex issues and their consequences, ability to recognize potential obstacles and work to resolve them within set timelines, resourceful and flexible in accepting change in priorities, excellent team player with experience in cross-functional teams, excellent communication skills.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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